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21 March 2013
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| [ Print-friendly version ] |
| Treatment of locally advanced or metastatic transitional cell carcinoma with cabazitaxel |
| ISRCTN | ISRCTN76947550 |
| DOI | 10.1186/ISRCTN76947550 |
| ClinicalTrials.gov identifier | NCT01668459 |
| EudraCT number | |
| Public title | Treatment of locally advanced or metastatic transitional cell carcinoma with cabazitaxel |
| Scientific title | Cabazitaxel in platinum pre-treated patients with locally advanced or metastatic transitional cell carcinoma who developed disease progression within 12 months of platinum based chemotherapy |
| Acronym | Cab B1 |
| Serial number at source | RRK4368 |
| Study hypothesis | The study aims to compare the overall response rate of cabazitaxel treatment versus best supportive care including single agent chemotherapy in patients with locally advanced or metastatic transitional cell carcinoma who developed disease progression within 12 months of platinum based chemotherapy. |
| Lay summary | Lay summary under review with external organisation |
| Ethics approval | NRES Ethics Committee East Midlands - Leicester, 15 October 2012, ref: 12/EM/0363 |
| Study design | Randomised open label parallel group study |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Transitional cell carcinoma |
| Participants - inclusion criteria |
1. Written informed consent
2. Age ≥ 18 3. Life expectancy ≥ 12 weeks 4. Patients with histology/cytology confirmed Transitional Cell Carcinoma (TCC) including mixed pathology with predominantly TCC, with locally advanced (T4b) or metastatic (lymph node or visceral) TCC arising from bladder or upper urinary tracts 5. Treated patients with incidental prostate cancer (pT2, Gleason ≤ 6) and PSA (Prostate Specific Antigen) ≤ 0.5 ng/mL are eligible 6. Measurable disease as per RECIST Criteria 1.1 7. ECOG Performance Status 0-1 8. Previously received first line platinum based treatment 9. Recurrence within 12 months (by RECIST criteria version 1.1) from last cycle of chemotherapy |
| Participants - exclusion criteria |
1. Previous therapy with a taxane
2. Pure non TCC histologies 3. Grade II or more peripheral neuropathy 4. Prior surgery, radiation, chemotherapy, or other anti-cancer therapy within 4 weeks prior to enrolment in the study 5. Uncontrolled severe illness or medical condition (including uncontrolled diabetes mellitus) 6. Inadequate organ and bone marrow function as evidenced by: 6.1. Hemoglobin < 9.0 g/dL 6.2. Absolute neutrophil count < 1.5 x 109/L 6.3. Platelet count < 100 x 109/L 6.4. AST/SGOT and/or ALT/SGPT > 2.5 x ULN 6.5. Total bilirubin > 1.0 x ULN 6.6. Serum creatinine > 1.5 x ULN. If creatinine 1.0 - 1.5 x ULN, creatinine clearance will be calculated according to CKD-EPI formula and patients with creatinine clearance ≤ 30 mL/min should be excluded 7. Symptomatic brain metastases or leptomeningeal disease (CT or MRI scan of the brain required only in case of clinical suspicion of central nervous system involvement). 8. History of another neoplasm except non-metastatic melanoma skin cancers, carcinoma in situ of the cervix, or cancer cured by surgery, small field radiation or chemotherapy < 5 years prior to randomization. 9. History of inflammatory bowel disease, significant bowel obstruction. 10. History of hypersensitivity to platinum, gemcitabine, taxanes, Polysorbate-80, or to compounds with similar chemical structures. 11. Any of the following events within 6 months prior to randomization: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft surgery, clinically symptomatic and uncontrolled cardiovascular disease, or clinically significant arrhythmias (grade 3-4). 12. Concurrent treatment with strong inhibitors of cytochrome P450 3A4 or patients planning to receive these treatments. For patients who were receiving treatment with such agents, a one-week washout period is required prior to randomization. 13. Women who are breastfeeding and women of child bearing potential (not postmenopausal (12 months of amenorrhea) or surgically sterile (absence of ovaries and/or uterus)) unless in agreement to use an adequate method of contraception during the treatment period and for 6 months after the last dose of the study drug. Men unless in agreement that they will use effective contraception (and condom to protect against exposure to seminal liquid) whilst participating in the trial and for 6 months after the last dose of study medication. |
| Anticipated start date | 01/12/2012 |
| Anticipated end date | 31/12/2015 |
| Status of trial | Ongoing |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Target number of participants | 96 (25 patients will be initially recruited and after intermin analysis, a further 71 patients may be recruited) |
| Interventions |
Cabazitaxel versus Best Supportive Care
Treatment duration: Up to 6 three weekly cycles of chemotherapy (18 weeks) |
| Primary outcome measure(s) |
Overall response rate: To compare the overall response rate of patients administered cabazitaxel vs best supportive care (including single agent chemotherapy) in patients with transitional cell carcinoma who have previously progressed on a platinum-based regimen.
Time Frame: Change from baseline at Week 9 and Week 18 |
| Secondary outcome measure(s) |
1. Overall survival: Defined as the time interval from the date of randomization to the date of death due to any cause. In absence of confirmation of death, survival time will be censored at the earlier of the last date the patient is known to be alive and the study cut-off date.
Time Frame: From date of randomisation to the date of tumour progression or death (from any cause) (or survival at study cut-off date), whichever came first up to 12months after the final patient has completed study treatment. 2. Quality of Life: QOL will be assessed by using a validated instrument; the EuroQOL (EQ-5D). Time Frame: Change from baseline at Week 6, Week 12, Week 18, Week 21 3. Safety and tolerability: Dose delays and dose reductions, adverse events, laboratory safety data. Time Frame: From date of randomisation up to 30 days after final dose of study medication |
| Sources of funding | Sanofi Aventis (France) |
| Trial website | |
| Publications | |
| Contact name | Dr Anjali Zarkar |
| Address |
Queen Elizabeth Hospital Birmingham
Cancer Centre |
| City/town | Edgbaston |
| Zip/Postcode | B15 2TH |
| Country | United Kingdom |
| anjali.zarkar@uhb.nhs.uk | |
| Sponsor | University Hospitals Birmingham NHS Foundation Trust (UK) |
| Address |
c/o Dr Chris Counsell
Queen Elizabeth Hospital Birmingham |
| City/town | Edgbaston |
| Zip/Postcode | B15 2TH |
| Country | United Kingdom |
| Sponsor website: | http://www.uhb.nhs.uk/ |
| Date applied | 01/11/2012 |
| Last edited | 08/03/2013 |
| Date ISRCTN assigned | 26/02/2013 |
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| © 2013 ISRCTN unless otherwise stated. | |
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